510(k) · Cleared
Recalled · 2007HP-1 (Healthpax)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdirections, Inc. · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cleared on Nov 28, 1988 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 28, 1988
- Review
- 81 days
- Class
- Class II
- Product code
- QJQ
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK883812 HP-1 (Healthpax)Healthdirections, Inc. · 1988
- Descendant · cites it directly · 4 of its ownK062284 Ces UltraNeuro-Fitness, LLC · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK230826 Modius SleepNeurovalens, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK252951 Genesis SleepNeurofield, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK232253 Modius StressNeurovalens Limited · 2024
- Descendant · 2 generations on · 0 of its ownK182311 CervellaInnovative Neurological Devices, LLC · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062284Ces UltraNeuro-Fitness, LLC · 2007 · cites it directly4descendants
- K230826Modius SleepNeurovalens, Ltd. · 2023 · 2 generations on1descendant
- K252951Genesis SleepNeurofield, Inc. · 2025 · 3 generations on0descendants
- K232253Modius StressNeurovalens Limited · 2024 · 2 generations on0descendants
- K182311CervellaInnovative Neurological Devices, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883812 | HP-1 (Healthpax) | Healthdirections, Inc. | 1988 | — |
| +1 | K062284 | Ces Ultra | Neuro-Fitness, LLC | 2007 | 1 |
| +2 | K230826 | Modius Sleep | Neurovalens, Ltd. | 2023 | — |
| +3 | K252951 | Genesis Sleep | Neurofield, Inc. | 2025 | — |
| +2 | K232253 | Modius Stress | Neurovalens Limited | 2024 | — |
| +2 | K182311 | Cervella | Innovative Neurological Devices, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJQ device
- #1 K252951 Genesis Sleepscore 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2007 | Not classified | Z-1242-2007 | Other | Peak voltage test result not in acceptable limits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062284 (Neuro-Fitness, LLC, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QJQ devicesQJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QJQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJQ
Too few QJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QJQ
No recall names QJQ since 2007.
Adverse event reports per year · QJQ
39in 2023
MAUDE reports naming product code QJQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K883812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883812: HP-1 (Healthpax).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883812
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026